Periodonitis and Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Periodonitis and Alzheimer's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05189132
• Other study ID #: University Lisbon
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: January 2023

Study information

• Verified date: June 2022
• Source: University of Lisbon
• Contact: Vanessa Rocha Rodrigues, Dr
• Phone: 919950890
• Email: vanessa_15_rodrigues[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to assess whether Periodontal Disease is more prevalent in adult patients diagnosed with Alzheimer's Disease compared to adult patients without Alzheimer's Disease.

The secondary objective is to describe and characterize the microbiological and biochemical profile of adult patients diagnosed with Alzheimer's Disease and compare with adult patients without Alzheimer's Disease.

Description:

To assess the possible association of Periodontal Disease with Alzheimer's Disease, I propose to carry out an observational, paired and cross-sectional study.

It will be evaluated whether adult patients diagnosed with Alzheimer's Disease have a higher prevalence of Periodontal Disease when compared to adult patients without Alzheimer's Disease.

As well, it will be evaluated whether adult patients with different stages of Alzheimer's disease have different stages of severity of Periodontitis.

The study sample will be obtained from the Associação Portuguesa de Alzheimer, in the Lisbon region, consisting of adult patients diagnosed with Alzheimer's Disease (test group).

The control group sample will consist of patients who attend consultations at the Faculty of Dental Medicine, University of Lisbon, matched for age, gender and other confounding factors, such as tobacco and systemic diseases (diabetes).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: January 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Will be included in the study all individuals who attend the Portuguese Alzheimer's Association, diagnosed with Alzheimer's Disease, who:

1. have voluntarily given their consent to participate;

2. due to cognitive or functional disability, they were unable to give free and informed consent, but they had this consent given by their representative

3. individuals who have participated in the cognitive assessment (only for the test group)

Exclusion Criteria:

• a) refused oral observation.

Related Conditions & MeSH terms

• Alzheimer Disease
• Periodontitis

Intervention

Diagnostic Test:
• Periodontal Diagnosis
All participants, in the test group and in the control group, will undergo an initial periodontal evaluation. The clinical evaluation will always be carried out by the same examiner, the author of the study, in order to guarantee calibrated observations. During data collection, intra-observer calibration will be performed, as recommended by the WHO (WHO, 1993), in order to minimize diagnostic variability and verify agreement
• Microbiological analysis
Microbiological analysis will be performed using a sample of subgingival bacterial plaque. The sample will be collected at the tooth and at the location with the highest probing depth values in each quadrant. A sterilized paper tip from the microbiological kit will be introduced to the bottom of the bag, with the aid of tweezers, remaining in the same position for 10 seconds. After collecting the sample, the paper tip will be placed in an individual transfer tube, properly identified. Afterwards, the sample will be sent to the laboratory, where a polymerase chain reaction (PCR) test is performed to identify the following bacteria - A. actinomycetemcomitans, T. forsythia, T. denticola, P. gingivalis, P. intermedia and F. nucleatum.
• Inflammatory mediators
The evaluation of inflammatory mediators will be performed with the aid of an absorbent paper strip, which is placed inside the periodontal pocket, for about 30 seconds. The sample will be taken from the tooth that has the highest probing depth values. The collected sample will be placed and stored in an individual transfer tube properly identified and in accordance with the laboratory's instructions. Afterwards, the sample will be sent to the laboratory, where the ELISA test is performed to quantify the following inflammatory mediators - IL-1ß, IL-6 and TNF-a.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Lisbon

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive Assessment	Cognitive assessment will be performed by neurologists from the Portuguese Alzheimer's Association.; Periodontal diagnosis will be performed, through clinical evaluation, to patients with and without Alzheimer's Disease. The Classification of Periodontal and Peri-implant Diseases and Conditions proposed by the American Association of Periodontology (AAP) and the European Federation of Periodontology (EFP) will be used to determine the prevalence of periodontal disease.; To assess whether adult patients with different stages of Alzheimer's disease have different stages of severity of Periodontitis (I, II, III and IV), in addition to a periodontal evaluation, it is also evaluated through cognitive tests, at which stage of the disease Alzheimer's patient is found.	Basline
Primary	Probing depth	The probing depth corresponds to the distance from the gingival margin to the bottom of the sulcus or periodontal pocket. Probing depth measurement will be performed at six locations per tooth, three locations per buccal and three locations per lingual/palatal	Basline
Primary	Clinical attachment level	The clinical insertion level corresponds to the distance from an enamel-cementary junction (JAC) to the bottom of the pocket.; In cases where there is gingival recession, the insertion level is complete through the sum of the probing depth value and the gingival recession value (distance from the gingival margin to the JAC).; In cases where the gingival margin coincides with the JAC, the insertion level value is the same as the probing depth.; If there is a pseudo-pocket, characterized by an increase in gingival volume in the coronal direction, the insertion level value will be the result of subtracting the probing depth value and the distance from the gingival margin to the JAC.	Basline
Primary	Plaque index	For the evaluation of the plaque index (PI), the PI developed by the authors Ainamo and Bay, in 1975, will be used. It is a dichotomous index, which assesses the presence or absence of bacterial plaque in the cervical area of the tooth in four locations, three locations by vestibular and one location by palatine	Basline
Primary	Bleeding on probing	Bleeding on probing is assessed by looking at bleeding points after periodontal probing. It will be evaluated in six locations per tooth, three locations per buccal and three locations per lingual/palatal. A red circle is placed around the sounding depth value (Lang 1986 and 1990).	Basline
Primary	Gingival Recessions	Gingival recession will be evaluated in millimeters and is obtained by the distance from the gingival margin to the JAC. It will be evaluated in six locations per tooth, three locations per buccal and three locations per lingual/palatal	Basline
Primary	Mobility	Mobility will be assessed with the handle of two instruments (probe and mirror), pushing the tooth in the buccolingual and occlusal-apical directions.; The classification proposed by Miller in 1950 will be used, which is divided into: Mobility 0: physiological (0mm to 0.2mm); Mobility I: < 1mm in the horizontal direction; Mobility II: > 1mm in the horizontal direction; Mobility III: horizontal and vertical mobility.	Basline
Primary	Furcation	The presence of furcation lesions will be evaluated using the Nabers probe. Will be used in the 1975 classification of Hamp; Grade 1 - Loss of horizontal insertion tissue less than 3mm; Grade 2- Loss of horizontal insertion tissue greater than 3mm, but the probe does not it passes from one side to the other.; Grade 3- Loss of horizontal insertion tissue greater than 3mm and the probe passes from side to side	Basline
Secondary	Microbiological analysis	Microbiological analysis will be performed using a sample of subgingival bacterial plaque. The sample will be collected at the tooth and at the location with the highest probing depth values in each quadrant.; A sterilized paper tip from the microbiological kit will be introduced to the bottom of the bag, with the aid of tweezers, remaining in the same position for 10 seconds. After collecting the sample, the paper tip will be placed in an individual transfer tube, properly identified. Afterwards, the sample will be sent to the laboratory, where a polymerase chain reaction (PCR) test is performed to identify the following bacteria - A. actinomycetemcomitans, T. forsythia, T. denticola, P. gingivalis, P. intermedia and F. nucleatum.	Basline
Secondary	Inflammatory Mediators	The evaluation of inflammatory mediators will be performed with the aid of an absorbent paper strip, which is placed inside the periodontal pocket, for about 30 seconds. The sample will be taken from the tooth that has the highest probing depth values.; The collected sample will be placed and stored in an individual transfer tube properly identified and in accordance with the laboratory's instructions. Afterwards, the sample will be sent to the laboratory, where the ELISA test is performed to quantify the following inflammatory mediators - IL-1ß, IL-6 and TNF-a	Basline